risques liés aux médicaments injectables risiken von...
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Risques liés auxmédicaments injectables
-Risiken von Parenteralia
Valia Humbert-Delaloye
congrès GSASA23-24 novembre 2006
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1650 1750 1850 19501700 1800 1900 2000
steam engines
railway
carphoto
telephone
PVCpiston motor
rubber plane
lyophilisation
fridge
vaccinationantibiotics
scanner, MRI
xenograft
blood circulation
injection on dog
infusions
injectionson humains
Pravaz syringe
hollow needle
Codex : injection solutions
transfusion catheters
polymeric venous
catheters
plastic syringes
Ph.H. V : iniectabilia
Codex : parenteral
route
transfusions prohibited
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intravenous administration
neutral pH � avoid pain
osmotic pressure ≈ plasma � avoid cell lysis
no particles � avoid many effects
� cross protective skin barrier
� direct contact with blood
sterility � avoid infections
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infusion line obturation
phlebitis
pulmonary impairment : mecanical obstruction, thromboembolism, granulomatous pneumonia, ARDS, pulmonary hypertension, death.
renal impairment : interstitial nephritis, granulomatous glomerulonephritis
ophtalmic, cardiac, hepatic, splenic impairment
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rapid action
systemic action
complete absorption
alternative to enteral route
less ADR on gastrointestinal tract
absence of smell or taste problems
numerous risks
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pain at the injection point
necessity of appropriate equipment
necessity of trained nurses
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preparation
administration route
administration rate
incompatibilities
physico-chemical instability
microbiological contamination
extravasation, local reactions, anaphylaxis, clotting, air embolism
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PreparationAdministration routeAdministration ratePhysico-chemical instabilityIncompatibilitiesMicrobiological contamination
potential preparation errors (14-20 %)dissolution solvent : volume and typedilution solute : volume and typefinal concentration
consequencespainhyper-, hypoosmolarityinstabilityincompatibilities
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PreparationAdministration routeAdministration ratePhysico-chemical instabilityIncompatibilitiesMicrobiological contamination
causesmental calculationignorance
strategies to reduce the riskinformation : Compendium, databases, labels, order entry systemsuse of standard solutions : tables, labels
PreparationAdministration routeAdministration ratePhysico-chemical instabilityIncompatibilitiesMicrobiological contamination
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databases
labels
order entry systems
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Preparation
Administration route
Administration ratePhysico-chemical instabilityIncompatibilitiesMicrobiological contamination
potential errors in administration routeperipheral instead of central linei.v. instead of sc/im (or opposite)i.t. instead of i.v.i.v. instead of per os
consequencespainthrombophlebitisinjection of particlessystemic action : e.g. ↑ heart rate, ↑ blood pressure, paralysis, …, death
strategies to reduce the riskinformationcentral catheter (dobutamine, amiodarone, …)
more diluted drugsorder entry systemsdifferent syringes (i.v. / per os)specific labelling and packaging of i.t.
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Preparation
Administration route
Administration ratePhysico-chemical instabilityIncompatibilitiesMicrobiological contamination
causesignoranceconfusionno other route availableimprecise medical order
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Preparation
Administration route
Administration ratePhysico-chemical instabilityIncompatibilitiesMicrobiological contamination
• route of administration highlighted
• labels on the syringe
• Luer slip syringes for i.t.
• i.t. transport + storage in separate container
• loud reading of drug labels
• vincristine in mini-infusion (extravasation)
• time interval
Fernandez CV et al. J Pediatr Hematol Oncol 1998; 20(6) : 587-590
i.t. administration of vincristine� paralysis, death
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PreparationAdministration route
Administration rate
Physico-chemical instabilityIncompatibilitiesMicrobiological contamination
potential errors in administration rate(18-38%)
overinfusion (more frequent)underinfusion
consequencesoverinfusion : hypotension, pain, nausea, vertigo, flushing, volemic overload, asystole, anaphylaxis, deafness, …
underinfusion : too lowconcentrations � inefficiency
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PreparationAdministration route
Administration rate
Physico-chemical instabilityIncompatibilitiesMicrobiological contamination
causesmental calculationerroneous pumps useignorance
strategies to reduce the riskinformation : Compendium, databases, labels, order entry systemsuse of standard solutions : tables, labelsuse of intravenous medication safety systemlearning + training
PreparationAdministration routeAdministration ratePhysico-chemical instabilityIncompatibilitiesMicrobiological contamination
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databases
labels
order entry systems
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PreparationAdministration routeAdministration ratePhysico-chemical instability
IncompatibilitiesMicrobiological contamination
potential incompatibilitiesbetween several drugs given togetherbetween drug and solventbetween drug and container
ü physical incompatibilities- visible (precipitate, color, gas)- prevention : avoid mixtures
adapt concentrations
ü chemical incompatibilities- often invisible (e.g. redox, hydrolysis,…)- hardly preventable
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PreparationAdministration routeAdministration ratePhysico-chemical instability
IncompatibilitiesMicrobiological contamination
concentrationpHlightoxygensalting outions : Mg2+, Ca2+, Fe3+
temperaturesolvent systemadsorption, adherencedissolution rate
causes
consequencesphysical : precipitate, inefficiencychemical : product destruction � inefficiency,
toxicity
Ø multiple lumina catheter
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PreparationAdministration routeAdministration ratePhysico-chemical instability
IncompatibilitiesMicrobiological contamination
proximale distale
médiane
voie distalevoie médiane
voie proximale
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PreparationAdministration routeAdministration ratePhysico-chemical instability
IncompatibilitiesMicrobiological contamination
Ø softwarenot convincing
Vogel et al. Anaesthesist 2003; 52(5) : 409-412
Ø colors (Schaffhausen)promising but limited accuracy
Ø tablesappreciated but
limited accuracy
Ø pharmacistcostly
Ø laboratory teststime problems
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PreparationAdministration routeAdministration ratePhysico-chemical instability
IncompatibilitiesMicrobiological contamination
• 34 beds university hospital adult ICU
• patients receiving >1 iv drug in the same line
• compatibilities between pairs of frequent drugs :
observation after 0, 15, 30, 60 min, 2, 4, 24 hwhite and black background
4 tests :1 : 1 mix1 : 4 mix4 : 1 mix1 : 1 no mix
• visual tests
• published data
CHUV(4242 pairs)
0.9 %
0.2 %
0.8 %
5.8 %
20.7 %
24.3 %
47.3 %
litt
incompatible (higher concentration)
incompatible (same or lower concentration)
controversial informations
no information
uninterpretable data
compatible (lower concentration)
compatible (same or higher concentration)
CHU Nancy (242 pairs)
litt
5.0 %
2.0 %
70.0 %
-
23.0 %
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0.7 %
0.7 %
0.02 %
0.02 %
17.2 %
20.3 %
61.1 %
labo
potential instabilitieswrong solvent / solutelimited products shelf life
causesignorancetoo long conservation
strategies to reduce the riskinformation : Compendium, databases, labelslight protection (Adalat�, Nimotop�, …)
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PreparationAdministration routeAdministration rate
Physico-chemical instability
IncompatibilitiesMicrobiological contamination
consequencesinefficiencytoxicity
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PreparationAdministration routeAdministration ratePhysico-chemical instability
IncompatibilitiesMicrobiological contamination
7121 observed preparations : - 2733 bags- 4388 syringes
no date : 17.5 %
invisible date : 22.8 %
respected validity : 57.0 %
unrespected validity : 2.7 %(insulin, furosemid, norepinephrin, …)
unknown validity : 40.3 %
� systematic labelling� frequent check
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PreparationAdministration routeAdministration ratePhysico-chemical instabilityIncompatibilities
Microbiological contamination
potential contaminationscontaminated infusionscontaminated lines
causesnumerous manipulationsmultiple-dose vialstoo long conservationsensitive products (dextrose, propofol)multiple lines, high number of luminacentral venous lines
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PreparationAdministration routeAdministration ratePhysico-chemical instabilityIncompatibilities
Microbiological contamination
consequences :bloodstream infections (3-5% in ICU)
1 infection=$ 6000 - $ 400001 infection=prolonged length of stay(1 week)
strategies to reduce the risklimited conservation : 24 h drugs, 72 h lineslimited manipulationsscrupulous hand washingsingle-dose vialsdecontamination of rubber stoppersterile syringe + needle for each sampling
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LabellingCalculationStabilityAdministration routeIncompatibilities
Microbiological contamination
contaminated iv line :coagulase-negative staphylococci, S. aureus
contaminated infusions :Gram neg bacilli, water organisms : Klebsiella, Enterobacter, Serratia, Pseudomonas
contaminated blood + lipid emulsions :Staphylococci
contaminated TPN :Candida, Enterobacter, Gram neg aerobic bacilli
Cunha B.A. Crit Care Clin 1998; 14 : 339-346
others (case reports) :HCV, P. falciparum
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LabellingCalculationStabilityAdministration routeIncompatibilities
Microbiological contamination
intrinsic contamination :- during manufacturing- rare, widely spread- eg. 378 cases of Enterobacter in 25 hospitals,
13.4 % mortality rate
Muder R.R. Infect Control Hosp Epidemiol 2001; 22(3) : 134-5
extrinsic contamination : - break in aseptic technique- hard to recognize, isolate cases- fever, hypotension
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LabellingCalculationStabilityAdministration routeIncompatibilities
Microbiological contamination
no conservativelipidic emulsion : bacterial + yeast growth� in vitro studies : contamination
in vivo : limited contamination (nonaseptic technique)
• fever, infections, sepsisK. pneumoniae, Moraxella osloensis, C. albicans, E. cloacae, S. marcescens, S. aureus, HCV, E. Coli, P. aeruginosa, S. epidermidis
� no need of laminar air flow
but � immediate use� single-use material� 8 h conservation
� 1 vial/person� desinfection� hand washing
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many advantages
injectable drugs :
several and various risks, from preparation to administration
� information
� focus on « at risk » situations
� initial learning + training(good handling technique)
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